Nutrition for Asthmatics

Official title

Individualized Nutrition to Help Asthmatics Improve Lung Function and Energetics (INHALE)

Overview

Determine to what extent three distinct dietary approaches improve asthma control and lung function.

Detailed description

This is a crossover design pilot trial that will recruit 15 adults with asthma. Participants will undergo screening and a lead-in period before being randomized to a series of three, 7-day diets with a 7+ day washout period between each diet. Asthma control and lung function will be assessed at the completion of each diet.

The goal of this pilot trial is to understand the effect of diet on asthma and conduct an exploratory analysis on factors that may predict the response to diet.

Interventions

• Other DGA Diet
  A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans (DGA) Including: * A variety of vegetables and fruits * Grains, at least half of which are whole grains * Fat-free or low-fat dairy * A variety of protein foods, including seafood, lean meats and poultry, eggs, legumes, nuts, and seeds * This healthy eating pattern also limits saturated fats and trans fats, added sugars, and sodium.
• Other MCT Diet
  A fully provisioned isocaloric, isonitrogenous study diet following the Dietary Guidelines for Americans supplemented with medium chain triglycerides (MCT).
• Other KETO Diet
  A fully provisioned isocaloric, isonitrogenous ketogenic study diet.

Primary outcome measures

• Asthma Control [Time frame: Baseline]
• Asthma Control [Time frame: After 7 days on Diet#1]
• Asthma Control [Time frame: After 7 days on Diet#2]
• Asthma Control [Time frame: After 7 days on Diet#3]
• Lung Function [Time frame: Baseline]
• Lung Function [Time frame: After 7 days on Diet#1]
• Lung Function [Time frame: After 7 days on Diet#2]
• Lung Function [Time frame: After 7 days on Diet#3]

Secondary outcome measures (12)

• Systemic inflammation [Time frame: Baseline]
• Systemic inflammation [Time frame: After 7 days on Diet#1]
• Systemic inflammation [Time frame: After 7 days on Diet#2]
• Systemic inflammation [Time frame: After 7 days on Diet#3]
• FENO [Time frame: Baseline]
• FENO [Time frame: After 7 days on Diet#1]
• FENO [Time frame: After 7 days on Diet#2]
• FENO [Time frame: After 7 days on Diet#3]
• FEV1/FVC [Time frame: Baseline]
• FEV1/FVC [Time frame: After 7 days on Diet#1]
• FEV1/FVC [Time frame: After 7 days on Diet#2]
• FEV1/FVC [Time frame: After 7 days on Diet#3]

Eligibility criteria

Inclusion criteria

• Age: 18-65 years
• BMI: 18.5 - 29.99 kg/m2
• asthma diagnosed by medical specialist (confirmed in medical history)
• partly controlled or uncontrolled asthma by Asthma Control Test score ≤22
• owns a device compatible with ZEPHYRx platform
• stable asthma medication use (no change in the past 2 months).

Exclusion criteria

• Diabetes or using diabetes medications that may lower blood glucose levels
• point of care fasting blood glucose ≥126 mg/dl or triglycerides ≥400 mg/dl
• current smoking or smoking history of greater than 10 pack-years
• other significant respiratory or cardiac disease or the presence of clinically important comorbidities, e.g., COPD, renal failure, liver disease; uncontrolled hypertension defined as systolic blood pressure ≥160 mm/Hg, or diastolic blood pressure ≥100 mm/Hg
• pregnant or nursing women
• food preferences or allergies inconsistent with study diet capabilities
• noncompliance with lead-in period requirements.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Pennington Biomedical Research Center — Baton Rouge

Identifiers

NCT: NCT06151405 · PBRC 2022-001 B · 1K01HL169491-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗